Argentum Medical, an industry leading manufacturer of antimicrobial wound dressings, announced today that it has received Class III medicated wound dressing CE Mark approval for its Silverlon® wound dressings. The CE mark designation will allow Silverlon dressings to be sold in the European Union and other countries requiring this approval. The CE mark designation recognizes that Silverlon dressings incorporate silver in the dressing and provide a local antibiotic action in the wound.
Clinical data reviewed by the Notified Body during the CE certification process presented Silverlon’s effectiveness in preventing infection, supporting wound healing, managing infected wounds and managing painful wounds.
Researchers at the University of South Florida, in a prospective, randomized, controlled trial, found that the use of Silverlon dressings reduced the surgical site infection rate for colorectal surgeries by 60% compared with control group. Their findings were published in August 2011 in the peer-reviewed journal Diseases of the Colon & Rectum. Other published studies have found similar results in open heart and spine surgery.
“Receipt of the CE mark for Silverlon as a Class III medicated wound dressing is a significant accomplishment for Argentum Medical,” states Raul Brizuela, President and CEO. “CE certification allows us to bring Silverlon’s infection fighting benefits to healthcare facilities across Europe and other parts of the world.”
Argentum Medical received the CE Mark for its entire line of Silverlon antimicrobial wound dressings which includes island dressings, wound pad dressings, wound contact dressings, wound packing strips, burn contact dressings, burn pad dressings, burn wrap dressings, acute burn glove dressings, EasyAg negative pressure dressings, negative pressure dressings, and IV/catheter dressings.
Silverlon wound dressings have a permanently plated metallic surface, which provides the antimicrobial benefits of silver without staining the skin and without increasing bioburden. Silverlon was originally developed for the U.S. military, where it is still extensively used for treatment of burn and blast injuries. Silverlon dressings are used today by surgeons and other healthcare professionals around the world on surgical wounds, IV and catheter-related wounds and to treat burns, skin grafts, and other chronic wounds.
Argentum Medical pioneered the use of silver plated nylon to help fight infection and facilitate wound healing. Specializing in the development of innovative products made from silver plated nylon, Argentum Medical will continue to explore new applications and markets for its Silverlon technology in keeping with its corporate mission to improve clinical outcomes.
